Nicotine Contraindications and Precautions
- angina
- cardiac arrhythmias
- myocardial infarction
- asthma
- breast-feeding
- children
- dental disease
- depression
- diabetes mellitus
- elderly
- esophagitis
- gastroesophageal reflux disease (GERD)
- hiatal hernia
- hypertension
- hyperthyroidism
- peptic ulcer disease
- pheochromocytoma
- pregnancy
- skin disease
- sodium restriction
- thyroid disease
- thyrotoxicosis
- tobacco smoking
Nicotine Contraindications and Precautions
Nicotine from drug products can be additive to the nicotine from tobacco; patients should be warned against continued tobacco smoking while using nicotine replacement products. Tobacco smoke contains hydrocarbons that induce hepatic CYP450 microsomal enzymes and thus tobacco smoking can increase the metabolism of many therapeutic drugs. Conversely, sudden smoking cessation may cause increased serum levels or effects of concomitant drug therapies (despite the use of a nicotine replacement product). Examples of drugs that may be affected include: caffeine, clozapine, oxazepam, olanzapine, pentazocine, phenothiazines, propoxyphene, propranolol (and possibly other beta-adrenergic blockers), theophylline, tricyclic antidepressants (e.g., imipramine), and warfarin. A decreased dosage of these drugs may be required at the cessation of smoking.
Tobacco smoke contains hydrocarbons that induce hepatic CYP450 microsomal enzymes and thus tobacco smoke can increase the metabolism of many therapeutic drugs. Because the process of smoking cessation may result in decreased clearance of medications used to treat asthma or depression, patients with these conditions are encouraged to check with their health care provider before pursuing nicotine therapy for smoking cessation.
For any smoker, with or without concomitant disease, the risk of nicotine replacement therapy in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement.
Cardiovascular effects of nicotine typically include peripheral vasoconstriction, tachycardia, and blood pressure elevation. The risks of nicotine replacement therapy in patients with certain cardiovascular and peripheral vascular diseases should be weighed against the benefits of including nicotine replacement in a smoking cessation program. The use of patches in a subject with preexisting cardiovascular disease does not appear to pose a greater risk than smoking itself, as long as the subject refrains from smoking while wearing the patch. Transdermal nicotine has been used safely as an aid to smoking cessation in patients with cardiac disease; however, those with a recent history (within the past 2 weeks) of unstable angina, myocardial infarction, CABG surgery, or cardiac arrhythmia were excluded. In general, nicotine replacement therapy should not be used in patients with serious cardiac arrhythmias, during the immediate post-myocardial infarction period, or in patients with severe or worsening angina pectoris. Nicotine therapy should be used with caution in patients with hypertension, pheochromocytoma, insulin-dependent diabetes mellitus, vasospastic diseases (e.g., Buerger’s disease, Prinzmetal’s angina), or thyroid disease resulting in hyperthyroidism or thyrotoxicosis, because increases in blood pressure, heart rate, and plasma glucose can follow the effects of nicotine-induced catecholamine release. Nicotine should also be used cautiously in patients on sodium restriction to help control high blood pressure and/or fluid retention. In a comparative trial, the combination of nicotine (Habitrol®) and bupropion (Zyban ®) for smoking cessation resulted in a higher incidence of treatment-emergent hypertension compared to either agent alone or to placebo. Most patients in the trial had evidence of preexisting hypertension. Monitoring for treatment-emergent hypertension is recommended in patients receiving the combination of nicotine and bupropion as well as for those receiving nicotine alone.
Clinical studies of nicotine dosage forms in elderly patients have not included sufficient numbers of patients > 65 years of age to determine if they respond differently to treatment than younger adults. However, clinical experience has not identified differences between older and younger patients. In general, dosage selection for elderly patients should be cautious, starting at the lower end of the dosage range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and concomitant disease.
Whenever possible, nicotine should be avoided during pregnancy; pregnant patients should seek qualified healthcare professional advice prior to use of non-prescription smoking cessation products. Pregnant smokers should be encouraged to stop smoking through educational and behavioral interventions before using pharmacological agents. Nicotine transdermal systems and inhalers are classified as FDA pregnancy risk category D and nicotine gum is classified as FDA pregnancy category C; however, conflicting information exists in many resources in regard to pregnancy safety ratings of these products. The specific effects of nicotine replacement therapy on fetal development are unknown; nicotine may increase fetal heart rate. Spontaneous abortion has been reported in pregnant women during nicotine replacement therapy; although a causal relationship has not been established, nicotine may have been a contributing factor. Studies of pregnant rhesus monkeys have shown that intravenous nicotine can decrease uterine blood flow and may produce acidosis, hypercarbia, and hypotension in the fetus. Teratogenicity has been noted in mice. The harmful effects of cigarette/tobacco smoking on maternal and fetal health are clearly established; effects include low birth weight, an increased risk of spontaneous abortion, and increased perinatal mortality. Nicotine replacement therapy should be used during pregnancy only if the likelihood of smoking cessation justifies the potential risk of nicotine replacement by the patient or the risk that the patient will continue to smoke.
Nicotine replacement therapy should be used with caution in women who are breast-feeding. Nicotine is distributed into breast milk. However, proper use of nicotine gum or transdermal or intranasal nicotine would be expected to produce lower concentrations of nicotine in milk than would cigarette smoking. Although some clearance of orally absorbed nicotine in infants will occur through first-pass metabolism in the liver, the efficiency of nicotine removal is probably lowest at birth. The safety of nicotine replacement therapy in nursing infants has not been examined. The decision of whether to use nicotine replacement therapy in a woman who is breast-feeding should be evaluated in comparison to the risks associated with exposure of the infant to nicotine and other tobacco contaminants in the breast milk as well as those of passive exposure to tobacco smoke.
Nicotine may delay healing in peptic ulcer disease. Therefore, nicotine should be used with caution in patients with active peptic ulcers. Nicotine replacement in a smoking cessation program should only be used when the benefits outweigh the potential risks.
The effectiveness of nicotine replacement therapy in children who smoke has not been evaluated. The amount of nicotine tolerated by adult smokers could produce toxic symptoms in children. Thus, nicotine gum or transdermal or intranasal nicotine should not be used in children.
Nicotine chewing gum is relatively contraindicated in patients with dental disease and in patients with temporomandibular joint (TMJ) disorder because injury to teeth or aggravation of TMJ can result from chewing.
Nicotine is relatively contraindicated in patients with a history of esophagitis, hiatal hernia, or gastroesophageal reflux disease (GERD) because these conditions can be exacerbated by nicotine’s pharmacologic effects. Mouth or throat inflammation may be irritated by the nicotine chewing gum formulation.
Nicotine transdermal systems may be irritating for patients with some types of skin disease such as atopic or eczematous dermatitis.
[ Last revised: 11/8/2005 5:40:00 PM ]
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